the life sciences industry (CRO, pharmaceuticals, biotechnology, etc). The ideal candidate will possess a deep understanding of GoodClinicalPractice (GCP) and its application in research studies. In addition, they will have proficiency in industry-standard clinical database applications, such as Electronic Data Capture (EDC … and Clinical Trial Management Systems (CTMS). Experience with programming languages like JavaScript or SQL is a strong plus. Company: CYTE is a full-service cardiovascular contract research organisation (CRO) powered by an integrated Clinical Research Platform and a Global Site Network. We provide research solutions to our … services. Role & candidate profile: Clinical Data Manager will ensure CYTE studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, CYTE SOPs and all applicable regulatory guidelines. Responsibilities: CRF design, database specification and edit check specification creation based on study protocols. EDC build and more »
Proclinical is seeking a dedicated Manager of Global Trial Optimisation. This role involves overseeing the clinical development strategy, clinical study concepts and protocols as well as operational plans. The successful candidate will play a crucial part in maintaining relationships with external experts to facilitate a wide source of … to meet deadlines, effective use of time, and prioritization. - Ability to influence and negotiate across a wide range of collaborators. - Knowledge of ICH/GCP and regulatory guidelines/directives. - Advanced project management skills, cross-functional team leadership, and organizational skills. - A minimum of a Bachelor's degree and relevant … industry experience. - Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. - Technical proficiency in trial management software and MS applications. Interested or know someone who might be? Reach out to Matthew Pike using the following: ✉️ m.pike@proclinical.com 📞 +44 207 4400 639 (5342) Apply more »
Proclinical is seeking a dedicated Manager of Global Trial Optimisation. This role involves overseeing the clinical development strategy, clinical study concepts and protocols as well as operational plans. The successful candidate will play a crucial part in maintaining relationships with external experts to facilitate a wide source of … to meet deadlines, effective use of time, and prioritization. - Ability to influence and negotiate across a wide range of collaborators. - Knowledge of ICH/GCP and regulatory guidelines/directives. - Advanced project management skills, cross-functional team leadership, and organizational skills. - A minimum of a Bachelor's degree and relevant … industry experience. - Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. - Technical proficiency in trial management software and MS applications. Interested or know someone who might be? Reach out to Matthew Pike using the following: ✉️ m.pike@proclinical.com 📞 +44 207 4400 639 (5342) Apply more »
of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »
s Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation. We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and … as well as a full range of local hospital and community services for people in Lambeth and Southwark. We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together … world-class clinical services, teaching and research. We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients. Job description more »
The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … goodclinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »
is currently collaborating with a CRO, who are actively seeking a Head of Quality Assurance to oversee and uphold the highest standards within our clinical research processes. In this pivotal role, you will lead a dedicated team committed to maintaining excellence and … driving continuous improvement. Your responsibilities will include ensuring that our operations align with the rigorous standards outlined in GoodClinicalPractice (GCP) guidelines and regulations. Please note that to be considered for this role you must have the right to work in this location. Key Responsibilities Create … within the pharmaceutical industry. Deep understanding of GoodClinicalPractice guidelines, regulations, and standards. Relevant certifications such as RQAP-GLP, RQAP-GCP are desirable. Leadership experience along with excellent communication, collaboration, and interpersonal skills. Detail-oriented with strong analytical and problem-solving abilities. Proven ability to drive more »
of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »
Job summary Clinical Specialist Radiographer/Technologist - PET-CT & CT OR Clinical Specialist Technologist - PET-CT London Location: Leaders of Oncology Care (main location) and The Harley Street Clinic Hours: Full Time 37.5 hours per week Shift times: 7.5 hour shifts Monday-Friday Salary: Up to … in particular Radiation Protection and Infection Control To assist with patient bookings and administrative duties where necessary To support departmental audits in accordance with clinical governance policies To ensure that quality assurance of equipment is carried out in line with departmental policy, recording and report faults in a timely … To assist with the implementation of new policies within the department and monitor their effectiveness To maintain a high standard of patient care through goodclinical practice. About us At The Harley Street Clinic and Leaders in Oncology Care, we provide a range of complex care services, specialising more »
Trial administration duties such as filing, kit inventory, booking couriers, research data entry, data presentation and assist in trial co-ordination in compliance with GoodClinical Research Practice. Main duties of the job To function as a member of the Trials team through provision of dedicated administrative support … to the clinical trials team. Working in a team to co-ordinate data collection for a caseload of patients participating in local, national and international trials in various treatment modalities and disease types. Disseminate information to consultants regarding new trials (including those on the NIHR Clinical Research Network … of the team. Provide support to other colleagues as required. Person Specification Education and Qualifications Essential BSc Life Science degree GSCE standard or equivalent GCP qualification Knowledge and Experience Essential Knowledge and experience with Multidisciplinary team and internal & external stakeholders Previous experience within haematology-oncology; or research Communication and Relationship more »
Chelsea and Westminster Hospital NHS Foundation Trust
Job summary We are looking for an experienced, enthusiastic, and motivated clinical pharmacist to join our established, friendly clinical pharmacy team. The post holder will be responsible for delivering clinical pharmacy services to a chosen sub-specialty of Medicine, which include Respiratory, Endocrinology, Gastroenterology, Cardiology, Care of … and Emergency Medicine. Main duties of the job Main duties include Acting as a role model and to deliver, develop and evaluate highly specialist clinical pharmacy services in accordance with the objectives set by the line manager. Providing a highly specialist clinical pharmacy service to patients within the … practicing pharmacist with the General Pharmaceutical Council Diploma in Pharmacy Practice or equivalent training Independent Prescriber or currently working towards IP Desirable ICH GCP Training Royal Pharmaceutical Society (RPS) faculty membership Postgraduate qualifications in Medical specialities Experience Essential Relevant and extensive post registration ward pharmacy experience including in medicine more »